Five-Year Observation of Remicade Treatment for Plaque Psoriasis in Austria (Study P04900)

NCT00725452 | Completed Results

• 1 other identifier: P04900
• Study Type: observational
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

Prospective, open-label-, 1-arm, multicenter observational study to determine the dose and interval of Infliximab infusions for subjects with plaque psoriasis.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Number of Therapies That Were Applied as Induction, Maintenance, or Episodic Therapies After One Infusion of Infliximab

  The types of therapies were assessed according to the following criteria: Induction therapy: first infusion given at Week 0 (Baseline). Second infusion given at Week 2 (+/- 7 days). Third infusion given at Week 6 (+/- 7 days). Maintenance therapy: given in approximately 8-week (56-day) intervals (time window +4 weeks to -2 weeks). One infusion given out of the time window was accepted to be classified as maintenance therapy, if the remaining infusions were given within the time window (8 weeks, +4 to -2 weeks). Episodic Therapy: given out of time frame (\> 12 weeks).

  Maximum 2 years

Secondary Outcomes (5)

• Mean Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy

  Maximum 2 years

• Median Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy

  Maximum 2 years

• Mean Dose of Infliximab

  Maximum 2 years

• Median Dose of Infliximab

  Maximum 2 years

• Mean Percent Change From Baseline in Body Surface Area (BSA) Involved With Psoriasis After Treatment With Infliximab

  Baseline and Infusion 9

Study Arms (1)

Infliximab

Subjects with plaque psoriasis will receive Infliximab initial induction therapy consisting of 3 Infliximab infusions at weeks 0, 2, and 6 given in specialized centers. A maximum of 6 maintenance infusions will be given in doses and intervals due to the discretion of the physicians.

Biological: Infliximab

Interventions

Infliximab BIOLOGICAL

Infliximab initial induction therapy consisting of 3 Infliximab infusions at weeks 0, 2, and 6 given in specialized centers. A maximum of 6 maintenance infusions will be given in doses and intervals due to the discretion of the physicians.

Also known as: Remicade, SCH 215596

Infliximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult subjects with moderate-to-severe plaque psoriasis will receive Infliximab induction therapy in specialized centers.

You may qualify if:

• According to the European Summary of Product Characteristics (SPC): Adult subjects with moderate-to-severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systematic therapy including cyclosporine, methotrexate, or Psoralen-ultraviolet-A light (PUVA).

You may not qualify if:

• According to the European SPC:
• Subjects with tuberculosis or other severe infections such as sepsis, abscesses, and opportunistic infections.
• Subjects with moderate-to-severe heart failure (New York Heart Association (NYHA) class III/IV).
• Subjects with a history of hypersensitivity to Infliximab or to other murine proteins or to any of the excipients.
• Subjects with elevated liver enzymes (\>5 upper limit of normal (ULN)).

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Centocor, Inc.: collaborator

MeSH Terms

Conditions

Psoriasis

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2008
• First Posted: July 30, 2008
• Study Start: October 1, 2006
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: July 28, 2015
• Results First Posted: September 2, 2011

Record last verified: 2015-07